Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission

Inclusion Criteria:

• Signed Informed consent.
• Initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma
• Women ≥ 18 years
• ECOG performance status ≤ 1 (Eastern Cooperative Oncology Groupperformance)
• Initial surgical cytoreduction as primary treatment combinated with Platinum- based chemotherapy administered as part of primary therapy.

Failure of the primary treatment as manifested by recurrent disease that have achieved a second or third complete response with a second or third-line chemotherapy (platinum-based or not).

The complete response to the second or third-line chemotherapy is defined as non symptoms of cancer persistence, normal CA-125 (cancer antigen 125), negative medical examination, and no evidence of disease in a TAC.

• At least 4 cycles of second or third-line chemotherapy must have been administered
• Surgery performed at first or second relapse in conjunction with second or third-line chemotherapy is permitted.

Exclusion Criteria:

• Acute or chronic infection
• Concomitant treatment with cancer chemo- and/or radiotherapy
• Exposure to an investigational product within 28 days of first infusion
• Previous treatment with murine monoclonal antibodies
• Inadequate renal function: creatinine >1.5 upper limit of normal [ULN] and/ or calculated creatinine clearance ≥ 50 mL/min
• Inadequate hepatic function (AST, ALT, >2.5 xULN; bilirubin >1.5 xULN), Hypoalbuminaemia < 3 g/dL
• Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1000 cells/mm3,
• Hb < 8g/dL and PTT > 2 x ULN
• Patients with occlusive intestinal or symptomatic sub-occlusive intestinal within the last 30 days.
• Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
• Unable or unwilling to comply fully with the protocol.
• Any co-morbid disease that would increase risk of toxicity according to investigator judgment
• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
• Exposure to investigational product, cancer, chemo-or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C) before first infusion
• Known or suspected hypersensitivity to catumaxomab or similar antibodies
• Long-lasting steroid treatment (≥ 7 days), Patients should only be included after stepwise discontinuation and free of steroids for a minimum of 5 days